Trastuzumab for HER2-positive breast cancer | Recurrent ovarian cancer | Solid malignant tumors

Inclusion criteria

• {"criterion_text":"- Signed written Informed consent approved by the relevant Ethics Committee (EC) or the Institutional Review Board (IRB)"}
• {"criterion_text":"- Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure"}
• {"criterion_text":"- Investigator's opinion that the patient continues to benefit from pertuzumab treatment"}

Exclusion criteria

• {"criterion_text":"- Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study"}
• {"criterion_text":"- Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study"}
• {"criterion_text":"- Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion 5 below."}
• {"criterion_text":"- More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study"}
• {"criterion_text":"- Left ventricular ejection fraction ≤ 50%"}
• {"criterion_text":"- Positive serum pregnancy test in women of childbearing potential (WOCBP) defined as pre-menopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization."}

Primary endpoints

• {"endpoint_text":"- AEs, serious adverse events (SAEs), AEs leading to pertuzumab discontinuation or dose interruption, and non-serious AEs of special interest (AESIs) Adverse events will be classified according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]","definition_or_measurement_approach":"Adverse events (AEs), SAEs, AEs leading to pertuzumab discontinuation or dose interruption, and non-serious AESIs will be collected and classified according to NCI CTCAE."}

Secondary endpoints

• {"endpoint_text":"- 1. Assessments of Progression free survival (PFS) will be done per Investigator’s assessment, based on local institution’s standard of care","definition_or_measurement_approach":"PFS assessed by Investigator per local institution's standard of care."}
• {"endpoint_text":"- 2. Overall Survival (OS)","definition_or_measurement_approach":"OS measured as time from defined baseline to death from any cause."}

Spain

Earliest CTIS Part Ii Submission Date

22-05-2024

Latest Decision Or Authorization Date

20-06-2024

Processing Time Days

29

Number Of Sites

2

Number Of Participants

10

Portugal

Earliest CTIS Part Ii Submission Date

22-05-2024

Latest Decision Or Authorization Date

17-06-2024

Processing Time Days

26

Number Of Sites

3

Number Of Participants

5

Italy

Earliest CTIS Part Ii Submission Date

22-05-2024

Latest Decision Or Authorization Date

24-06-2024

Processing Time Days

33

Number Of Sites

2

Number Of Participants

8

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Parexel International Corp.

Responsibilities

code:6

Name

Alira Health S.r.l.

Responsibilities

code:10

Name

Almac Pharma Services Limited

Responsibilities

code:3

Name

Fortrea Development Limited

Responsibilities

Monitoring

Third parties

• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"code:6","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Alira Health S.r.l.","duties_or_roles":"code:10","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Pharma Services Limited","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"Monitoring","organisation_type":"Pharmaceutical company"}